15^th July 2020

To Our Valued Customers,

RE: Therapeutic Goods Administration (TGA) Post Market Review on PPE Including Masks.

An article has been released detailing concerns by the Public and Australian Government regarding the quality of masks that were imported to assist with the COVID-19 Pandemic. We believe it is best to explain Orien’s part in the TGA Post Market Review and assure our customers that there are no concerns regarding the supply of Orien masks.

Changes to Regulation Due to COVID-19 Pandemic

In March 2020, Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 was made to assist in stockpiling PPE items to support our Health Care workers. The emergency exemption is a positive initiative implemented by the Australian Government to assist in obtaining PPE products to keep our front-line workers safe by reducing required paperwork and waiting times of approval so prompt delivery can be made of these type of products.

Why Was There An Audit

Unfortunately, since this Exemption was made, there have been concerns of quality with certain Masks that have been imported and a Post Market Review has been conducted to assess the compliance of these masks to international standards and ensure they meet certain criteria required by the TGA.

Result of Audit

Every sponsor that has an ARTG Entry (TGA Registration) for Masks were contacted to provide evidence including Manufacturers Declaration of Conformity declaring the product is made to a specific recognized international standard.

Orien was contacted in relation to 4 individual ARTG Entries that we listed for 4 individual mask manufactures.

We responded to the TGA’s request with Manufactures Declaration of Conformity Certificates and evidence supporting manufacturing standards on ALL ARTG Entries and this was accepted by the TGA 6 weeks ago.

Of the 4 ARTG Entries listed by Orien, MyDent International Level 3 Earloop Masks were included. We had sold out of these masks and unfortunately, we are unable to obtain any more stock for the foreseeable future. Therefore, we decided rather than continuing the registration and paying the registration fee, it was best to cancel this ARTG Entry.

This extract by the TGA website clearly explains the nature of a cancellation of an ARTG Entry.

"The ARTG entry for a face mask may be cancelled in two ways: The sponsor (the supplier within Australia) may voluntarily cancel the entry or the TGA may cancel the entry. With respect to the ARTG entries voluntarily cancelled by the sponsor, it is important to note that these devices are not subject to a recall action. This is because the TGA has not received any evidence for those entries about their compliance to any manufacturing standards. The TGA holds no evidence that these devices failed to meet appropriate manufacturing standards or that they failed to perform as intended. The decision to cancel the ARTG entry was made solely by the sponsor."

The 3 remaining ARTG Entries will continue to be listed and all the relevant documentation/evidence has been provided to the TGA and accepted.

We will continue to stock and supply these masks to our valued customers.

I can assure you, all masks that are/have been listed on the TGA Registry are compliant with relevant manufacturing standards and this documentation can be supplied to any of our customers upon request.

We thank you for your continued trust and support.

Kind Regards,

Erdem Salih

Managing Director

Orien Dental Supplies